THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip TB-0520FCRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04953170370519), received between Oct 5, 2016 and Jul 15, 2024 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Oct 22, 2025Class IIOpen, Classified

   Firm is initiating a removal due to continued reports of adverse events.

   Z-1376-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SUBJECT DEVICE FELL INTO THE PATIENT'S ABDOMINAL CAVITY AND WAS RETRIEVED WITH FORCEPS. THE PATIENT WAS NOT IMPACTED AS THE FALLING PART WAS REMOVED IMMEDIATELY AND IT TOOK 1-MINUTE TO RETRIEVE THE BROKEN SUBJECT DEVICE. THE PATIENT IS IN GOOD HEALTH AND HAS BEEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19746169 ↗
• MalfunctionJan 31, 2024Material Separation; Material Separation

  IT WAS REPORTED, THE THUNDERBEAT PAD WAS BADLY WORN, THE FRONT END WAS COCKED AND COULD NOT BE USED NORMALLY. THERE WAS NO PART OF THE DEVICE THAT FELL OR FELL INTO THE PATIENT¿S BODY. THE THERAPEUTIC TOTAL HYSTERECTOMY WAS COMPLETED USING A REPLACEMENT DEVICE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18619098 ↗
• MalfunctionAug 29, 2023Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE TEFLON PAD ON THE ULTRASOUND KNIFE CAME OFF WITHIN 10 MINUTES DURING A THERAPEUTIC RIGHT LIVER RESECTION PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER DEVICE WITH A DELAY OF 15 MINUTES. THERE WAS NO REPORT OF PATIENT OR USER INJURY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17646350 ↗
• MalfunctionMay 19, 2023Fracture; Fracture

  A CUSTOMER REPORTED TO OLYMPUS, DURING A THERAPEUTIC PAROTID GLAND OPERATION THE THUNDERBEAT¿S NEEDLE CORE OF THE KNIFE HEAD WAS BROKEN AND INOPERABLE. THE PROCEDURE WAS DELAYED NO MORE THAN 15 MINUTES AND COMPLETED USING A REPLACEMENT DEVICE. THE SUBJECT DEVICE BROKE OUTSIDE OF THE PATIENT¿S BODY CAVITY. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16966777 ↗
• MalfunctionMay 18, 2023Fracture; Fracture

  A CUSTOMER REPORTED TO OLYMPUS, DURING A THERAPEUTIC PAROTID GLAND SURGERY THE THUNDERBEAT¿S NEEDLE CORE OF THE KNIFE HEAD WAS BROKEN AND INOPERABLE. THE EVENT OCCURRED AT THE BEGINNING OF THE PROCEDURE. THE PROCEDURE WAS DELAYED NO MORE THAN 15 MINUTES AND COMPLETED USING A REPLACEMENT DEVICE. THE SUBJECT DEVICE BROKE OUTSIDE OF THE PATIENT¿S BODY. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16953913 ↗
• MalfunctionJan 28, 2022Material Separation; Material Separation

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, THIRTY MINUTES INTO A THERAPEUTIC OPEN RADICAL TREATMENT FOR ENDOMETRIAL CANCER PROCEDURE, U508 ALARMS FOR SHORT CIRCUIT WERE RECEIVED ON THE PROCESSOR FOR THE DEVICE IN THE FREE ILIAC ARTERY. THE DEVICE TEFLON PAD WAS WORN, SEPARATED, AND FELL OFF. THE SEPARATED PIECE WAS RETRIEVED FROM THE PATIENT. THERE IS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13385346 ↗
• MalfunctionFeb 6, 2020Break; Break

  DURING A PANCREATECTOMY WITH SPLENECTOMY, THE SUBJECT DEVICE WAS USED. AFTER 2 HOURS SINCE THE SURGERY BEGAN, THE PROBE OF THE SUBJECT DEVICE BROKE OFF OUTSIDE THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9675114 ↗
• MalfunctionSep 25, 2019Break; Break

  DURING AN UNSPECIFIED LAPAROSCOPIC PROCEDURE, THE SUBJECT DEVICE WAS USED. AFTER ONE ACTIVATION, THE TISSUE PAD OF THE SUBJECT DEVICE WAS DAMAGED AND SEPARATED. NO FURTHER INFORMATION WAS PROVIDED. ON SEPTEMBER 24, 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE TISSUE PAD OF THE SUBJECT DEVICE WAS PARTIALLY SEPARATED. THIS IS THE REPORT REGARDING THE SEPARATION OF THE TISSUE PAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9114750 ↗
• MalfunctionAug 2, 2018Failure to Deliver Energy; Failure to Deliver Energy

  DURING AN OPEN SPLENECTOMY, THE SUBJECT DEVICE WAS USED. THE DEVICE DID NOT SEAL THE VESSEL. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7741809 ↗
• MalfunctionOct 5, 2016Break; Break

  THE SUBJECT DEVICE WAS USED DURING A RESECTION OF KIDNEY TUMOR. THE PTFE PAD OF THE DEVICE WAS PARTIALLY SEPARATED. THERE WAS NO PATIENT HARM REPORTED. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6002060 ↗
• MalfunctionOct 5, 2016Break; Break

  THE SUBJECT DEVICE WAS USED DURING A NEPHRECTOMY. AFTER SHORT TIME USE, THE PTFE PAD OF THE DEVICE WAS PARTIALLY SEPARATED. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6002058 ↗